Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymph… (NCT06561048) | Clinical Trial Compass
RecruitingPhase 3
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
United States150 participantsStarted 2024-10-02
Plain-language summary
A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult participants ≥18 years of age on the day of signing the informed consent form.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
✓. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
✓. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.
✓. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.
✓. Life expectancy \>12 weeks.
✓. Adequate organ function as determined by:
✓. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:
Exclusion criteria
✕. Participants who have T-cell lymphoma with active central nervous system involvement.
What they're measuring
1
Progression-free survival
Timeframe: Up to 4 years post study treatment initiation
✕. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
✕. History of primary immunodeficiency or sold organ transplantation.
✕. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
✕. Any active infection requiring IV therapy.
✕. History of invasive prior malignancy that required systemic therapy within last 3 years.
✕. Any condition that confounds the ability to interpret data from the study.
✕. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody.